Job Detail

Req #: 1900067


Location: Boudry, Neuchatel, Switzerland


Job Category: Technical Development


Work Location: Route de Perreux 1 2017


Organization: Manufacturing Services


Employee Status: Full-time


Job Type: Regular


Other Locations: United States-New Jersey-Summit

As Project Lead, you are responsible for “in time” and “in budget” realization of this (and potentially other) Capex projects. The role will lead world class project execution of overall project phases, starting with the “feasibility studies & project initiation” ranging over all planning phases including preparation of Capital Appropriation Request (CAR), till the start up. This will also, take all measures to achieve or exceed the required GMP standards and perform qualification for enabling start-up projects. Upon completion of the project, be responsible for successful commissioning/handover/startup.

After commissioning, handover and start-up, the Project Lead would potentially transition into site head or manufacturing head depending on the selected candidate experience/qualification as well as the success of these Capex projects.

Primary Responsibilities:

• Represent user of these facilities as leader, together with the project manager(s) of these Capex projects from Global Engineering, to jointly lead all phases of capex projects from feasibility study till project start-up (IOP/Q).


• Provide technical leadership and management of user team (comprising manufacturing, validation, maintenance, quality, IT, tech transfer, etc.) responsible for these project executions.


• Oversee 1st tech transfer of clinical and/or commercial products into these facilities.  For commercial product, oversee the Process Performance qualification (PPQ) prior to full commercial operations.


• Require 25% of time for traveling to lead project execution.

Education and Qualification Requirements:

• Bachelor of Science degree in Biological Sciences, Biomedical/Chemical Engineering, or Engineering; a combination of experience and advanced education in other disciplines may also be considered


• Minimally 15+ years of biotech, cell therapy, or pharmaceutical industry experience in process development, process scale up/manufacturing, tech transfer and process validation.


• Experience with commercial scale manufacturing support for cell culture, aseptic final product filling/kitting/labeling, liquid media manufacturing (vials, bags, bottles) and/or analytical reagent (e.g. endotoxin detection assay) manufacture, current Good Manufacturing Practices, and US / EU regulations.


• Strong leader, motivating team player, drives results, excellent communication skills.


• Capable of managing diverse stakeholders in multicultural environments.


• Experienced in Project management with demonstrated track record to lead through influencing.


• To qualify as the site head / manufacturing head of these facilities, the candidate should have prior, relevant experience in running the cGMP operations in Pharmaceutical industry.

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